Immunovia (IMMNOV) Investor update summary

PancreaSure and clinical performance

• PancreaSure is a five-biomarker blood test using an algorithm to produce a positive or negative result; it launched in the U.S. in September 2025.

• In CLARITI and VERIFI, stage 1–2 sensitivity was 77.6% and specificity 92%; stage 1 sensitivity was 75.7%.

• MRI and CT sensitivity for early-stage disease was cited at ~50%; the blood test offers a 2–3-day turnaround after lab receipt.

• Five-year survival was cited at 3% for widespread disease, 42% when cancer remains in the pancreas, and >80% at stage 1A.

Commercial traction and reimbursement

• 36 high-risk surveillance programs were using PancreaSure; 10 of the top 20 U.S. cancer centers had used it since launch.

• Adoption involves integrating the test into clinic protocols; high-risk centers are using it quarter-over-quarter, with repeat testing and future orders expected to support accelerating volume.

• Commercial insurance billing began in February 2026, with early signs of reimbursement; a Medicare coverage application was submitted in September to MolDX.

• Medicare reimbursement is set at $897 per test; coverage could support volumes among patients over 65 and influence commercial insurers’ coverage decisions.

• ASSURE is a real-world registry study intended to complement payer evidence and provide clinicians with information on test use.

Market and growth opportunities

• U.S. addressable market for guideline-defined high-risk patients was estimated at $2.5bn; eligible groups include people with family history, genetic mutations or pancreatic cysts.

• Annual testing of high-risk individuals could generate recurring revenue; management cited low cost of goods sold as supporting attractive margins.

• AI is being used to optimize the test’s biomarker algorithm and to identify potential patients through electronic health records and imaging.

• Business development is exploring partners in China and Japan; U.S. commercial-partner discussions have continued with about a dozen potential partners.